Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
denufosol tetrasodium · 6 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| denufosol tetrasodium Inhalation Solution | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| denufosol tetrasodium Inhalation Solution | DRUG | 60 mg by oral inhalation three times daily |
| 0.9% w/v sodium chloride solution | DRUG | 0.9% w/v sodium chloride solution by oral inhalation three times daily |
| denufosol tetrasodium (INS37217) | DRUG | - |
Inclusion Criteria: * Have a confirmed diagnosis of CF * Have oxyhemoglobin saturation ≥ 95% prior to randomization Exclusion Criteria: * Have acute intercurrent respiratory infection (cough, wheezing, or new rhinorrhea or nasal congestion) * Have any significant medical condition not related t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
Denufosol tetrasodium is an investigational small molecule being studied for the treatment of cystic fibrosis lung disease. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development but is not approved by the FDA.
Denufosol tetrasodium is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with cystic fibrosis.
Denufosol tetrasodium is in Phase 2 clinical development for cystic fibrosis lung disease. It has completed Phase 1 pharmacokinetic studies in healthy volunteers. The drug remains investigational and has not received FDA approval.
Denufosol tetrasodium has completed four clinical trials. Two Phase 2 studies in cystic fibrosis patients are NCT00103714 and NCT00130182. Two Phase 1 pharmacokinetic studies in healthy volunteers are NCT00210054 and NCT00210093. All trials are completed.
Denufosol tetrasodium is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for cystic fibrosis lung disease. The drug has completed clinical studies but remains in development and has not been authorized for commercial use.